New company, no employees, Setting up a QMS

A

apinop

#1
Good day!

I have been reading this forum occasionally and found lots of good stuff, especially as regards to how things work in real life, as opposed to how they should work in theory. :)

Now, I am faced with a bit of a predicament: we are starting a new company, with other two business partners, in a regulated industry (aviation). The company will do airspace design.

As part of the approval process we are required to implement a quality management system and write the corresponding manual. ISO 9001 external certification is not a requirement but we may go for it for commercial reasons nevertheless.

I have been through some of the posts in here, notably the FAQ, and found some good applicable advice such as [1] and [2]. I also have some experience with implementing QMS in the past, but in a very different context (big multinational where new departments / outposts are created, but the job is well known, everyone are trained and used to working together, massive commitment and help from the company behind, etc.)

This time:

  • Completely new company.
  • Just the three of us.
  • No employees for the first 12-18 months.
  • Although we're setting up an office for commercial reasons, most of the job will at first be done remotely. There is no point in driving ten miles just to sit in front of my laptop, I can do that at home, unless I need to print something on the plotter or meet a client or another partner (and the cafe downstairs is closed).


So it's a pretty minimal operation, three experienced dudes typing away on their laptops.


Much of ISO 9001 is just sensible practices that we already follow anyway, in what are still our respective "day" jobs.


Now my questions are:

  • Could anybody point me to any threads in here, dealing with the specifics of achieving ISO 9001 compliance in a no-employees company context? I expect advice for self-employed people and the like may also be helpful.
  • My biggest problem at the moment is that in theory, operations cannot start until the company gets its approval, for which a QMS documented in a QMM is necessary. This means describing processes and procedures from a purely theoretical point of view. How the hell do I do this? :confused: Also, I expect our processes will be very fluid and subject to major change in the first few months, as we build our systems.


I would be very grateful indeed for any pointers that you may offer! :)



This following bit may be safely skipped.


Lastly, I'd like to say, for a bit of a rant, that I feel there is also a lot in ISO 9001 that we would be having to document just to show it to the auditor. E.g., 5.2.1, having a quality policy that "includes a commitment to satisfy applicable requirements". That's kind of the default isn't it? Why on Earth would someone not agree to satisfy applicable requirements? If anything, a deviation from such commitment is what should be documented. It's the same as those quality policies where the company commit themselves to "comply with all applicable laws and regulations". I feel that's a bit superfluous as... well, it's a legal requirement anyway so you're bound to do it whether you like it or not. :rolleyes:


Links:

[1] https://elsmar.com/Forums/showthread.php?t=32766
[2] https://elsmar.com/Forums/showthread.php?t=62559
 
Last edited by a moderator:
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: New company, no employees, QMS

I would be very grateful indeed for any pointers that you may offer!
The way I see it, you do have employees: the 3 partners; that's your organization.

As for the quality manual dilemma, developing an "unorthodox" quality manual for this start-up should be an easy task, but the question would then be: would this simplified quality manual be acceptable to whomever is asking that of you?

Unfortunately, you might be dealing with an organization that is set in stone in archaic ways, expecting 150 pages of utter non-sense with the cover page titled QUALITY MANUAL..

I would try to approach someone at this customer's organization involved with supplier approval and attempt to ascertain if they would be willing to accept an atypical quality manual. In case of a positive answer, you could have a very abbreviated manual, complying with, e.g., ISO 9001:2015.

As for relevant threads, try:
https://elsmar.com/Forums/showthread.php?t=4866
https://elsmar.com/Forums/showthread.php?t=38900

Good luck
 

BoardGuy

Quite Involved in Discussions
#3
You do not indicate which revision of ISO 9001 you will be implementing but I would assume ISO 9001:2015. Your management system for quality should reflect how the business is operating today in that you will be working remotely.

The first real phase is to document what you are doing today without using the requirements of the standard. Use the titles from the standard but don’t try to address the actual requirements, just write what you do or will be doing.

The second phase is to come to agreement between the existing partners and assign responsibilities and authorities as appropriate. Which partner will maintain the documentation and records, who has responsible for reviewing customer contract requirement etc?

Third phase is to then compare what has been written to the actual requirements of the standard and revise as needed. The partner assigned to that area within the standard should do the revision of the documentation as needed.

Forth phase is really finalization of documentation through review and agreement by the partners. Once agreement is reached, assign one individual to review and edit the created documentation so that they have a single voice to them and a unified flow.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
..... I have been reading this forum occasionally and found lots of good stuff, especially as regards to how things work in real life, as opposed to how they should work in theory. :)

Now, I am faced with a bit of a predicament: we are starting a new company, with other two business partners, in a regulated industry (aviation). The company will do airspace design.
Aerospace, I assume.

...my questions are:

  1. Could anybody point me to any threads in here, dealing with the specifics of achieving ISO 9001 compliance in a no-employees company context? I expect advice for self-employed people and the like may also be helpful.
  2. My biggest problem at the moment is that in theory, operations cannot start until the company gets its approval, for which a QMS documented in a QMM is necessary. This means describing processes and procedures from a purely theoretical point of view. How the hell do I do this? :confused: Also, I expect our processes will be very fluid and subject to major change in the first few months, as we build our systems.
My advice would be to look through discussions here on small company implementations. Three people is not zero employees, but even if you say you have none now, eventually you will.

If you haven't made a business plan, do so.

Do "theoretical" process maps as part of your business plan and be as detailed as you can predict. Sure, they will change as the business actually starts operation, but if/as the business grows they will change any way. All things start with theory.

Think of it this way - You are making a model. Be as realistic as you can.


..... Lastly, I'd like to say, for a bit of a rant, that I feel there is also a lot in ISO 9001 that we would be having to document just to show it to the auditor. E.g., 5.2.1, having a quality policy that "includes a commitment to satisfy applicable requirements". That's kind of the default isn't it? Why on Earth would someone not agree to satisfy applicable requirements? If anything, a deviation from such commitment is what should be documented. It's the same as those quality policies where the company commit themselves to "comply with all applicable laws and regulations". I feel that's a bit superfluous as... well, it's a legal requirement anyway so you're bound to do it whether you like it or not. :rolleyes:
Some things are just obvious as you have observed. I think right now you are over thinking things.
 

normzone

Trusted Information Resource
#5
... document what you are doing today without using the requirements of the standard ...

... come to agreement between the existing partners and assign responsibilities and authorities as appropriate. Which partner will maintain the documentation and records, who has responsible for reviewing customer contract requirement etc? ...

... then compare what has been written to the actual requirements of the standard and revise as needed. The partner assigned to that area within the standard should do the revision of the documentation as needed. ...

Forth phase is really finalization of documentation through review and agreement by the partners. Once agreement is reached, assign one individual to review and edit the created documentation so that they have a single voice to them and a unified flow.
AND THIS SET OF STEPS is how everything should get done in any organization anyway - you will rinse and repeat this operation many times if your company is successful, so start practicing now :D
 
A

apinop

#6
Re: New company, no employees, QMS

Wow! I didn't expect such a quantity and quality of replies. Thank you very much to all of you.

To briefly respond to some of the comments:

From Sidney:

The way I see it, you do have employees: the 3 partners; that's your organization.
Yes, you are correct. I made the distinction because it so happens that the entire workforce are also the organisation's top management. Implicitly, ISO 9001:2015 seems to assume that those two groups will be distinct, although I imagine that a good auditor will know how to deal with this.

As for the quality manual dilemma, developing an "unorthodox" quality manual for this start-up should be an easy task,
This is exactly what I want to do. Not (just) because it would be relatively easy, but mainly because I'm convinced that this is what would suit my organisation.

[...] but the question would then be: would this simplified quality manual be acceptable to whomever is asking that of you?

Unfortunately, you might be dealing with an organization that is set in stone in archaic ways, expecting 150 pages of utter non-sense with the cover page titled QUALITY MANUAL..
And there you go... spot on. We are talking aviation here. We still use TELEX. Need I say more? :)

I would try to approach someone at this customer's organization involved with supplier approval and attempt to ascertain if they would be willing to accept an atypical quality manual.
This, Sidney, is indeed the best piece of advice that we could possibly receive. From our dealings so far, they have been quite helpful so there is a possibility this approach may actually fly. If nothing else, it means less work for them too.

A clarification: It is not a customer organisation that requires the manual, it's a requirement from the Civil Aviation Authority (what would be the FAA in the States) in order for us to obtain the necessary approval. The three major requirements are: a) qualifications of the people doing the work, b) presenting a QMM (the requirement is for a manual, not a system, oddly enough), and c) complying with two European Regulations: Regulation (EU) No. 73/2010, and Regulation (EU) No. 1029/2014 (a minor update to the former). This part does require a QMS, but not a QMM :rolleyes:

BoardGuy:

You do not indicate which revision of ISO 9001 you will be implementing but I would assume ISO 9001:2015.
I did not indicate it on purpose, because the national authority's requirements do not actually mention that the quality manual has to be ISO-compliant, although on the other hand the EU Regulations mentioned above do say that the QMS having been certified as ISO-compliant is considered sufficient evidence of compliance, in lieu of an audit from the national authority (but they can still audit us nonetheless). With that said, my reference is the 2015 revision, if nothing else because we may still wish to seek certification from an approved body for commercial reasons.


The first real phase is to document what you are doing today without using the requirements of the standard.
Today we are not actually doing anything that would fall within the scope of the QMS, since we're dealing with the various administrative and practical bits involved in actually setting up the company, but with that said, your four-step programme seems sound, and is very close to the iterative approach I have used in the past. :agree1:

Basically, I may end up with a longish manual first, which then I'll trim down to the essential bits. Much like I used to do for my uni assignments, each of which started life as a Tolstoyan epic.

Use the titles from the standard but don’t try to address the actual requirements, just write what you do or will be doing.
Very useful tip, thanks!

Marc:

Hello, and many thanks for running this forum. It is indeed a bit of a treasure trove, isn't it? :)

Aerospace, I assume.
Nope, airspace. As in, deciding in which bits of sky aircraft are going to be flying. So different set of regulations altogether compared to the fellows that make the aeroplanes. Closer to, but still different from, air traffic control.

My advice would be to look through discussions here on small company implementations.
Done! :agree1:

Three people is not zero employees, but even if you say you have none now, eventually you will.
That is true, if the first phase goes according to plan, we'll be hiring down the line.

Do "theoretical" process maps as part of your business plan
Ah, another bit of good advice, cheers! I had actually started doing exactly this, but I felt like I was shooting in the dark. Your comment reassures me a lot in this respect.

Btw, yes we do have a business plan at the moment, all four pages of it, and that's perfect at this stage. If I have time to make our quality manual about the same length, I will be very happy indeed (if I don't have time, it'll have to be longer).

Some things are just obvious as you have observed.
I guess I'm worried about the auditor asking "why haven't you put this in writing?" I could say that it is implied in our mission statement (e.g., the customer focus thing) or in our core values (the "don't be a crook" part), but I don't know how well that'll go down if, as Sidney warns, we get some dinosaur who likes to assess compliance using a bathroom scale.

I think right now you are over thinking things.
Yup! Though I'm a bit more at ease now having read your practical, insightful comments.

Thank you all once again! :bigwave:
 
Thread starter Similar threads Forum Replies Date
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Certifying a "virtual" company with zero employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
U Internal auditing - Company employees or contract second party Internal Auditing 10
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
H How to Establish and Document Competence of Employees in a Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Stijloor Calculating (3rd Party) Audit Days for Company with Seasonal Employees General Auditing Discussions 3
P Small company of approx 28 Employees - ISO-9001:2008 Guidelines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P Audit Man Day Requirements - Small AS9100 Company hiring New Employees AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
M Certifying a company with two employees to ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Audit Mandays vs. Number of Company Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Can a Company get away with not having Employees Trained to the Processes they use? Training - Internal, External, Online and Distance Learning 2
J Small Laboratories & ISO 17025 Clause 4.1.4 - Small company 4 employees ISO 17025 related Discussions 13
P ISO 9001 Company Quality Objectives and Targets - Communication to Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Does your Company Supply Calipers for Employees? Manufacturing and Related Processes 59
K Trainer Requirements for Internal Company TS16949 Training Course for Employees? Training - Internal, External, Online and Distance Learning 3
C First Audit Stop - Employees Washroom - Learn all you need to know about a company General Auditing Discussions 83
C % of management -vs- employees in your company? Career and Occupation Discussions 5
L Ensuring All Employees Comply To Company Quality Requirements Misc. Quality Assurance and Business Systems Related Topics 6
K Implementing TL 9000 from scratch - Small (3 paid employees) company Various Other Specifications, Standards, and related Requirements 3
N How does your Company Communicate Requirements to Employees Other ISO and International Standards and European Regulations 24
S TS 16949 Clause 4.1 - Process and methodologies - Small software company 15 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Mission Statement - Employees should know our company Mission Statement verbatim? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Audits in a tiny Dx Company Internal Auditing 33
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L Implementing the PRRC role in a company EU Medical Device Regulations 5
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 11
qualprod Corona virus Contingency plan - What have you done in your company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Client Communication - SaaMD company Misc. Quality Assurance and Business Systems Related Topics 3
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5
E Company A supplies pharmaceuticals to the MOI - Who is responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom